Hysteroscopic fundal fixation of LNG-IUS in adenomyosis: a prospective feasibility and safety study

Background Expulsion of the levonorgestrel-releasing intrauterine system (LNG-IUS) limits its effectiveness in adenomyosis management, particularly in patients with anatomical risk factors. This study aimed to assess the feasibility and short-term safety of a novel hysteroscopic fixation technique designed to improve device retention.

In this single-center prospective feasibility study, 52 patients with adenomyosis underwent placement of a modified LNG-IUS (integrated with a GyneFix anchor) using a customized delivery cannula under hysteroscopic guidance. Feasibility outcomes included successful device deployment and procedural time. Safety outcomes included intraoperative complications, device expulsion rate at 6 months (exploratory), and adverse events. Symptom changes (pain VAS, menstrual PBAC scores) were assessed as exploratory endpoints.

The procedure was successfully completed in all 52 patients (100%) with a mean operative time of 23.9 ± 8.1 min. No intraoperative complications occurred. During the 6-month follow-up, no device expulsions were observed (0%; 95% CI: 0–6.8%). Symptom assessments indicated reductions in median pain VAS scores (from 7.2 to 2.8) and PBAC scores. Irregular bleeding was common initially, persisting as light spotting in 18 patients (34.6%) at 6 months.

This feasibility study suggests that the novel fundal fixation technique is technically achievable and appears safe in the short term for patients with adenomyosis who have completed childbearing. The observed device retention rate is encouraging, but requires confirmation in larger comparative studies with longer follow-up. Similar content being viewed by others Data availability All data generated or analysed during this study are included in this published article [and its supplementary information files].

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Not applicable. Funding This work was supported by the Research Grant of Center for Science and Technology Development in Medicine and Health, National Health Commission (Nos. WKZX2024GQ0317). Author information Authors and Affiliations Contributions Conception and design: C Li; Collection and assembly of data: L Wang, F Song; Data analysis and interpretation: Y Xu , L Zhang; Administrative support: W Wang and B Wei; Manuscript writing: All authors; Final approval of manuscript: All authors. Corresponding authors Ethics declarations Ethics approval and consent to participate This study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol received ethical approval from the Institutional Review Board of the Second Affiliated Hospital of Anhui Medical University (Approval No. SL-XJS2024-043). Written informed consent to participate was obtained from all participants prior to enrollment. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Additional information Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Supplementary Information Supplementary Material 1. Rights and permissions Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. About this article Cite this article Li, C., Wang, L., Xu, Y. et al. Hysteroscopic fundal fixation of LNG-IUS in adenomyosis: a prospective feasibility and safety study. BMC Women's Health (2026). https://doi.org/10.1186/s12905-026-04438-7 Received: Accepted: Published: DOI: https://doi.org/10.1186/s12905-026-04438-7